2023-508664-30-00招募中3 期
Efficacy and tolerance of nicotinamide supplementation during acute kidney injury: a prospective randomized double-blind trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 10
- 主要终点
- rate of complete renal recovery (success) assessed at day + 21 post-randomization. The complete renal recovery, (success) will be defined from the estimated glomerular filtration rate (eGFR): - if baseline eGFR is unknown; an eGFR >60ml/min (at day+21 according to the mention above) - if baseline eGFR is available; by the return to baseline eGFR +/- 3.
研究概览
简要总结
To demonstrate the superiority of nicotinamide (NAM) to achieve the complete renal recovery in patients with a persistent acute kidney injury (stage 2 or 3 in KDIGO classification) despite 24h with standard care, between two therapeutic strategies:
- Administration of NAM
- Standard of care
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Admitted to an adult intensive care unit of nephrology or Nephrology department
- •Age 18 years or more
- •Persistent acute kidney injury stage 2 or 3 in KDIGO classification despite 24h with standard care to treat pre-renal acute kidney injury according Acute Disease Quality Initiative (ADQI) workgroup
- •Suspected acute tubular necrosis as primary cause of acute kidney injury
- •Free from mechanical ventilation; hemodynamic support and non-invasive ventilation are allowed
- •Subject affiliated to or beneficiary of a social security system
- •Subject having signed written informed consent
排除标准
- •Acute kidney injury stage 1 (due to a very high rate of renal recovery and no potential impact of nicotinamide) in accordance with the 2019 reviews
- •Moribund status (defined by the expectation of death in less than three months)
- •Liver failure (to prevent NAM liver toxicity) according to the definition in MODS above)
- •Thrombocytopenia < 50 G/L (which might occur in patients requiring dialysis and receiving NAM)
- •Known allergy to NAM
- •Taking supplemental nicotinamide or niacin (other nicotinamide supplements to be ceased 4 weeks prior to study randomization)
- •Ongoing participation in a concurrent interventional study
- •Pregnancy or breastfeeding and all other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without content, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations
- •Severe cognitive or psychiatric disorders
- •Inability to provide informed consent, or unwillingness to participate in the study
- •Patients with limited French proficiency
- •Acute kidney disease (AKD) defined by AKI persisting more than 7 days and less than 3 months according ADQI workgroup
- •Patients not in capacity to consent and without legal representatives present to receive information and consent for the participation of the patient
- •End stage renal disease with chronic renal replacement therapy (intermittent hemodialysis or peritoneal dialysis)
- •Chronic kidney disease with glomerular filtration rate ≤ 15 ml/min/1.73m2
- •History of kidney transplantation
- •Mechanical ventilation
- •Conditions requiring vitamin B3 supplementation: Nutritional deficiency or alcohol abuse.
- •Multiple organ dysfunction syndrome (MODS) based on modified Surviving Sepsis Campaign criteria (21). Patients with two or more organ dysfunctions other than kidney dysfunction will be categorized as having MODS. Respiratory dysfunction is defined as a PaO2/FiO2 ratio <200 and requiring mechanical ventilation. Shock status is defined as hypotension (systolic blood pressure <90 mm Hg or mean arterial pressure <70 mm Hg) that requires the use of norepinephrine > 15 μg/min. Hepatic dysfunction is defined as serum bilirubin level >2 mg/dL. Hematologic dysfunction is defined as a blood platelet count <100,000/μL. Coagulopathy is defined as an international normalized ratio >1.
- •Metabolic dysfunction is defined as a serum lactate level >2 mmol/L.
- •Primary cause of AKI other than suspected ATN (renal obstruction, glomerulonephritis, immuno-allergic nephritis).
结局指标
主要结局
rate of complete renal recovery (success) assessed at day + 21 post-randomization. The complete renal recovery, (success) will be defined from the estimated glomerular filtration rate (eGFR): - if baseline eGFR is unknown; an eGFR >60ml/min (at day+21 according to the mention above) - if baseline eGFR is available; by the return to baseline eGFR +/- 3.
rate of complete renal recovery (success) assessed at day + 21 post-randomization. The complete renal recovery, (success) will be defined from the estimated glomerular filtration rate (eGFR): - if baseline eGFR is unknown; an eGFR >60ml/min (at day+21 according to the mention above) - if baseline eGFR is available; by the return to baseline eGFR +/- 3.
次要结局
未报告次要终点
研究者
nephrologist
Scientific
Assistance Publique Hopitaux De Marseille
研究点 (10)
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